Kornimate/medical-research-clean huggingface dataset:
pragmatic factorial trial of hydroxychloroquine, azithromycin, or both for treatment of severe sars-cov-2 infection

Conditions: SARS-CoV-2

Summary: this is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed sars-cov-2 infection. participants who are hospitalized and have a positive nucleic acid amplification test for sars-cov-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: arm 1: standard of care alone arm 2: standard of care plus hydroxychloroquine participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. this will effectively result in four treatment groups: 1. standard of care alone 2. standard of care plus hydroxychloroquine 3. standard of care plus azithromycin 4. standard of care plus hydroxychloroquine plus azithromycin


Eligibility criteria:
inclusion criteria: 1. admitted to participating hospital with symptoms suggestive of covid-19 infection or develop symptoms of covid-19 during hospitalization 2. subject (or legally authorized representative) can provide written informed consent (in english or spanish) affirming intention to comply with planned study procedures prior to enrollment 3. male or female adult aged 12 years or older at the time of enrollment 4. has laboratory-confirmed sars-cov-2 infection determined by a validated nucleic acid amplification assay (public health or commercial) in any respiratory specimen collected within 14 days of randomization 5. illness of any duration that includes * radiographic evidence of pulmonary infiltrates (chest x-ray or ct scan) or * clinical documentation of lower respiratory symptoms (cough, shortness of breath, wheezing) or * any documented spo2 ≤ 94% on room air or * any inpatient initiation or supplemental oxygen regardless of documented cause exclusion criteria: 1. participating in any other clinical trial of an experimental agent for covid-19 2. on hydroxychloroquine at any time during hospitalization, or within 180 days of hospitalization for covid-19 regardless of indication 3. history of g6pd deficiency, cirrhosis, long qt syndrome or porphyria of any classification 4. most recent ecg prior to time of screening with qtc of ≥500 msec 5. known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives 6. death anticipated within 48 hours of enrollment 7. inability to obtain informed consent from the patient or designated medical decision maker

Keywords: covid-19
multi-dimensional signatures for precisely predicting the response and prognosis of lung cancer patients

Conditions: Response; Prognosis

Summary: this study aims to determine the clinical effectiveness of multi-dimensional signatures in predicting response and prognosis of lung cancer patients. the study is a multi-center perspective research of treatment planning for patients with lung cancer. to characterize clinical effectiveness, the progression-free survival (pfs) and overall survival (os) impacts of multi-dimensional signatures will be estimated.

multi-dimensional signatures, including ngs-based genotyping, and other essential detections such as immunohistochemistry (ihc), provides an opportunity to improve outcomes for patients by tailoring treatments to each individual's genomic profile. this is a multi-center single arm research study integrating multi-dimensional signatures into clinical decision-making for patients with lung cancer. the clinical effectiveness of multi-dimensional signatures is unknown in the real-world of clinics. to identify a counterfactual for pred-lung approach, matching methods combined with administrative healthcare data will be used. the survival impacts of pred-lung approach compared to usual care in matched controls will then be estimated.

Eligibility criteria:
inclusion criteria: * patients with locally-advanced or metastasis lung cancer * life expectancy \> 3 months exclusion criteria: * age at diagnosis \<18 * refuse to enroll

Keywords: multi-dimensional signatures ngs lung cancer
mindfulness-based "stop (stop, take a breath, observe, proceed) touching your face" intervention

Conditions: Face-touching Behavior

Summary: this single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "stop touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like covid-19.

background face-touching behavior often happens frequently and automatically, and poses potential risk for spreading infectious disease. mindfulness-based interventions (mbis) have shown its efficacy in the treatment of behavior disorders. this study aims to evaluate an online mindfulness-based brief intervention skill named "stop (stop, take a breath, observe, proceed) touching your face" in reducing face-touching behavior. methods this will be a single-blind, randomized, controlled, trial. we will recruit 1,000 participants, and will randomize and allocate participants 1:1 to the "stop touching your face" intervention group (n=500) and the control group (n=500). all participants will be asked to monitor and record their face-touching behavior. the intervention group will receive the brief online mindfulness-based "stop touching your face" program, and the control group will receive control intervention. primary outcome will be the efficacy of short-term mindfulness-based "stop touching your face" intervention for reducing the frequency of face-touching. the secondary outcomes will be the reduction of the duration of face-touching after intervention; the correlation between the psychological traits of mindfulness and face-touching behavior; and the differences of face-touching behavior between left-handers and right-handers. we will recruit 1000 participants from april to june 2020 or until the recruitment process is complete. the follow-up will be completed in june 2020. we expect all trial results to be available by the end of june 2020. discussion this is the first rct to evaluate the efficacy of brief mindfulness intervention to reduce face-touching behavior. we expect that "stop touching your face" has a significantly greater reduction the frequency of face-touching behavior than the control intervention. as "stop touching your face" is a brief and simple skill, the public health impact of its expansion world-wide could be enormous, helping us to manage any face-touching spread infectious diseases, like coronavirus disease 2019 (covid-19).

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. being able to access online services 3. being able to read and write in chinese 4. expressing an interest in participant this study 5. willing to provide informed consent to participate in the study exclusion criteria: 1. under 18 years of age 2. unable to access online services 3. unable to read and write in chinese
sagittal imbalance and lumbar stenosis surgery: decompression without implant

Conditions: Lumbar Stenosis, Familial

Summary: lumbar stenosis (lss) is the most frequent degenerative lumbar disease and is the most frequent indication for spinal surgery. when non-invasive treatments fail, decompression surgery is the gold standard therapy for the majority of patients and generally improves symptoms. however, few studies have investigated the improvement in posture (radiological parameters) after surgery. in lumbar stenosis, patients may present a forward leaning posture (to relieve pain), which is responsible for sagittal imbalance. the aim of this prospective study was to evaluate the repercussions of decompression surgery on sagittal balance and to compare these with aux clinical results. investigators included patients operated on for isolated lumbar canal stenosis.


Eligibility criteria:
inclusion criteria: 1. symptoms and signs of neurogenic claudication and radiological signs of central lumbar stenosis; 2. patients undergoing open decompression surgery ≤ 3 levels, 3. all patients with symptoms that did not respond to at least 3 months of non-invasive treatment. exclusion criteria: patients were excluded from the study if they had one or several of the following clinical and/or radiological criteria: 1. spondylolisthesis (disc slip \> 5 mm), 2. criteria showing instability (variation of \> 10° in the angle formed by the vertebral endplates on dynamic images). 3. scoliosis (cobb angle \> 20 °). 4. patients lost to follow-up were excluded.
evaluation of the quality of care in the emergency department by studying the appropriateness of admissions of patients accessing the emergency department (fondazione irccs ca' granda ospedale maggione policlinico)

Conditions: Quality of Care; Evaluation; Emergency Department; Appropriateness

Summary: the aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the emergency department to admit or not to admit patients.

the information normally recorded in the emergency department medical record will be used, as well as the available clinical and administrative databases. for reasons of feasibility, the investigators will also restrict the analysis to patients coming to the emergency department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility criteria:
inclusion criteria: * adult patients * presentation in the emergency department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness. exclusion criteria: * voluntary removal of the patient; * sending home with instructions to return for further services
fiber and metformin combination therapy in adolescents with severe obesity and insulin resistance

Conditions: Obesity, Childhood; Insulin Resistance

Summary: this is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (met) alone and in combination over 12 months on glucose metabolism (insulin resistance \[ir\]), inflammation and bmi in adolescents with obesity and ir, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function. since met and fiber have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of fiber + met will have a synergistic effect and be more effective than fiber or met alone in improving metabolic function (ir) and reducing bmi and inflammation in adolescents with obesity, ir and family history (fm) of t2dm. .


Eligibility criteria:
inclusion criteria: 1. age 12-18 years 2. bmi percentile \> 95% for age/sex; 3. total weight fluctuation over past 6 months \< 10%; 4. homa-ir \> 3.16; 5. fh of t2dm (first or second-degree relative). exclusion criteria: 1. current use of insulin or diagnosis of t2dm; 2. systolic or diastolic blood pressure (bp) \> 99th percentile for age and sex; 3. acute infectious or inflammatory condition over the preceding 1 month; hospitalization \> 48 hrs; 4. history of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders; 5. active malignancy; 6. concomitant use of medication/investigational drug known to affect body weight in the past year; 7. antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in the past 30 days; use of lipid-lowering and anti-inflammatory medication.

Keywords: dietary fiber metformin
comparative acute effects of r-mdma and s-mdma in healthy participants

Conditions: Healthy

Summary: racemic ±3,4-methylenedioxymethamphetamine (mdma) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. these acute subjective effects of mdma may be helpful to assist psychotherapy and mdma has been investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

mdma is a racemic substance containing equal amounts of the enantiomers s(+)- and r(-)-mdma. preclinical research indicates that s-mdma mainly releases dopamine (da), norepinephrine (ne), serotonin (5-ht), and oxytocin while r-mdma may act more directly on 5-ht2a receptors and release prolactin (prl). animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of mdma and that s-mdma is mainly responsible for psychostimulation while r-mdma may have fewer adverse effects and have greater prosocial effects. a human study conducted between 10/2022 and 01/2024 by our team compared the effects of r-mdma, s-mdma, and racemic mdma revealing that both enantiomers have generally similar effects. however, the study did not administer equivalent doses of r- and s-mdma. in the present study a single dose of r-mdma and a single dose of s-mdma, now adjusted and presumed to be equivalent, will be compared.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years 2. good understanding of the german language 3. understanding of procedures and risks associated with the study 4. willing to adhere to the protocol and signing of the consent form 5. willing to refrain from the consumption of illicit psychoactive substances during the study 6. willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car) 7. willing to use effective birth-control throughout study participation. 8. body mass index 18 - 34.9 kg/m2 exclusion criteria: 1. relevant chronic or acute medical condition 2. current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder 3. psychotic disorder or bipolar disorder in first-degree relatives 4. hypertension (sbp\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. illicit substance use (not including cannabis) more than 20 times or any time within the previous month. 6. pregnancy or current breastfeeding 7. participation in another clinical trial (currently or within the last 30 days) 8. use of medications that may interfere with the effects of the study medication 9. tobacco smoking (\>10 cigarettes/day). 10. excessive consumption of alcoholic beverages (\>15 drinks/week)
reference population for speckle tracking imaging

Conditions: Left Ventricular Function

Summary: the scar study uses a software program entitled qlab, a proprietory program, developed by philips healthcare (philips healthcare, andover, ma). literature on two-dimensional speckle tracking imaging (2dste) is growing, but data relevant to the population in the scar study is minimal. accumulation of data relevant for a population of subjects will provide a set of normal values for interpretation of 2dste and minimize any influences from differences in data produced from different companies. this data may also assist other researchers investigate other cardiac diseases and abnormalities.


Eligibility criteria:
inclusion criteria: * be between the ages of 20 - 80 years at study entry * provide written informed consent and be able to comply with study procedures, including permission to access medical records * have a bmi index equal to or less than 35 * less than 5% risk of developing coronary artery disease as determined using the combined diamond/forrester and cass data (acc stable cad guidelines) exclusion criteria: * have taken cardioactive drugs within 6 months prior to examination * these include but are not limited to beta-blockers, calcium channel blockers, and angiotensin converting enzyme inhibitors * currently clinically significant chronic or acute illness * documented cardiovascular disease * possess abnormal cardiac structure and function after examination with routine echo * this may include valvular defects, left ventricular hypertrophy, cardiomyopathies or pericardial disease * documented congenital heart conditions or defects * history of diabetes * be unwilling to provide voluntary consent

Keywords: speckle tracking echocardiography database
determining the optimal dose of ad-209 in patients with essential hypertension

Conditions: Hypertension,Essential

Summary: the purpose of this study is to determine the optimal dose of ad-209 in patients with essential hypertension.

condition or disease : hypertension intervention/treatment drug : ad-209-h drug : ad-209-m drug : ad-209-l drug : placebo drug : amlodipine drug : telmisartan phase : phase 2

Eligibility criteria:
inclusion criteria: * signed informed consent * other inclusions applied exclusion criteria: * orthostatic hypotension with symptom * other exclusions applied
evaluation of nail fold microcirculation in ckd

Conditions: Chronic Renal Disease

Summary: to evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy

the aim of this study is to study the changes of nailfold microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of nailfold microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.

Eligibility criteria:
inclusion criteria: * ckd patients * without dialysis * blood pressure ≤ 140/90mmhg exclusion criteria: * polycystic kidney * endocrine system disease * cardio-cerebrovascular disease * rheumatic immune disease * peripheral vascular disease * hematological diseases * respiratory disease * infection

Keywords: chronic renal disease nail fold microcirculation interventional therapy
periprosthetic bone remodeling in femoral neck fracture patients; a 5-year follow up study

Conditions: Bone Mineral Density; Femoral Neck Fractures

Summary: periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.

between january 2014 and july 2017 a rct was conducted at sorlandet hospital kristiansand, norway. the trial was approved by the regional ethics committee (2013/1853/rek) and registered at clinicaltrials.gov (clinicaltrials.gov identifier nct02028468).patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.a subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this dexa study, and future examination of bone remodeling in these patients is now planned.

Eligibility criteria:
inclusion criteria: * patients between 70 and 90 years of age with displaced femoral neck fractures * intact cognitive function * ability to walk with or without a walking aid prior to falling. exclusion criteria: * dementia * fractures in pathologic bone * patients not belonging to the hospital community * patients with sepsis or local infection * fracture not eligible to be treated with a hemiarthroplasty
low-intensity focused ultrasound and the complex patient

Conditions: Opioid Use Disorder; Chronic Pain; Anxiety Disorder

Summary: studying the effects of low intensity focused ultrasound (lifu) on measures of pain, craving, and anxiety in a complex patient population.


Eligibility criteria:
inclusion criteria: 1. males and females aged 18-65 years 2. current diagnosis of chronic back pain as defined by pain duration of at least three months, with back pain being an ongoing problem for at least half the days of the last six months. 3. have evidence of central sensitization (cs) as measured by the widespread pain/symptom severity index (wpssi) with a score of widespread pain index (wpi) ≥ 7 and symptom severity (ss) ≥ 5 or wpi = 3-6 and ss ≥ 9. 4. meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for current opiate use disorder as diagnosed by the structured clinical interview for dsm-5. 5. be in treatment for opioid use disorder (oud) including buprenorphine or methadone. 6. meet the dsm-5 criteria for a current anxiety disorder: generalized anxiety disorder, post-traumatic stress disorder or social anxiety disorder as diagnosed by the structured clinical interview for dsm-5. exclusion criteria: 1. evidence of neuropathic pain 2. previous spine surgery 3. current substance use disorder other than oud or tobacco use disorder 4. current dsm-5 diagnosis of schizophrenia or schizo-affective disorder 5. chronic pain conditions other than chronic back pain 6. daily opiate use other than buprenorphine/methadone for oud/pain control 7. pregnant or breastfeeding 8. history of head injury, seizures, neurologic disorders including cerebrovascular disease, stroke, brain surgery, brain tumor, multiple sclerosis, or neurodegenerative diseases 9. history of metastasizing cancers, inflammatory disorder (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, lupus or polymyositis), unintended weight loss of 20 pounds or more in the last year, or cauda equina syndrome 10. ferromagnetic implants or other contraindications for magnetic resonance imaging (mri) 11. evidence of arteriovenous malformation, aneurysm, infarct, meningioma, parenchymal brain tumor or evidence of neurodegenerative processes and/or white matter lesions greater than that expected for age as determined by the study neuroradiologist 12. unstable medical conditions such as congestive heart failure, unstable angina, poorly controlled arrhythmia active system infection end stage renal disease
evaluation of effectiveness and safety of bioresorbable vascular scaffold in routine clinical practice

Conditions: Arterial Occlusive Diseases; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease

Summary: the purpose of this study is to evaluate the relative effectiveness and safety of bioresorbable vascular scaffold compared to other (drug eluting stents) des.


Eligibility criteria:
inclusion criteria: * age 19 and more * intervention with bioresorbable vascular scaffold * agreed with written informed consent form exclusion criteria: * bypass graft surgery (cabg) recommended * lesion with previous bypass graft surgery (cabg) * severe calcification and/or severe tortuosity * contraindication to antiplatelet agent or inability to take dual antiplatelet therapy within 1 year * life expectancy of 1year and under * subjects scheduled to receive cardiac surgery or serious non-cardiac surgery * cardiac shock

Keywords: bioresorbable vascular scaffold routine clinical practice angioplasty, transluminal, percutaneous coronary coronary artery disease drug eluting stent